Sr Regulatory Affairs Specialist

This is a remote position and the ideal candidate will be located near Mansfield, MA or Waukegan, IL.

What Regulatory Affairs contributes to Cardinal Health

Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.

Regulatory Affairs plans, coordinates and implement regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.

Job Summary:

The Sr Regulatory Affairs Specialist will support the Medical Solutions Regulatory Affairs team. They are responsible for providing regulatory support on a range of medical devices. This includes support of change development projects, new product development, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business.

Responsibilities

• Under direction of manager, support new and modified product development projects to establish and integrate regulatory strategy into project activities.
• Lead, under direction of manager, the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs.
• Collaborate with internal Cardinal international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution.
• Review design control documents including documents associated with design inputs and design outputs.
• Review product labeling for compliance with global labeling regulations.
• Review advertising and promotional literature for compliance with applicable regulations.
• Under direction of manager, interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business.
• Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.
• Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc.
• Assists in the development, maintenance and implementation of regulatory procedures and SOPs.

Qualifications

• Bachelor’s degree or equivalent work experience preferred.
• 1-3 years Regulatory Affairs experience in the Medical Device industry preferred.
• Strong proficiency in Microsoft Office Applications preferred.
• Ability to manage multiple projects, while having strong organization skills, problem solving skills and being team oriented preferred.
• Strong interpersonal skills preferred.
• Strong verbal and written communication skills preferred.
• Ability to travel up to 10% of the time.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks.
• Works on projects of moderate scope and complexity.
• Identifies possible solutions to a variety of technical problems and takes actions to resolve.
• Applies judgment within defined parameters.
• Receives general guidance may receive more detailed instruction on new projects.
• Work reviewed for sound reasoning and accuracy.

Anticipated salary range: $76,700 - $98,550

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 2/25/2026 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day.